Kornimate/medical-research-clean huggingface dataset:
lu177-eb-psma617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: in prior studies, the investigators synthesized 177lu-eb-psma-617 by conjugating a truncated evans blue (eb) molecule and dota chelator onto psma-617 and labeled it with 177lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177lu-eb-psma-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mcrpc). this study was performed to evaluate the safety and therapy response to 177lu-eb-psma-617 in patients with mcrpc. this is an open-label, randomized study. different groups with doses of 1.11gbq (30 mci), 2.00 gbq (54 mci) and 3.7gbq (100 mci)of 177lu-eb -psma617 will be injected intravenously. all patients will undergo 68ga-psma pet/ct scans before and after the treatment.

prostate cancer (pc) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. recent studies have demonstrated the possibility of 177lu-psma-617 therapy as a viable treatment option in mcrpc. to increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177lu, the investigators conjugated a truncated evans blue (eb) molecule and dota chelator onto psma-617 (eb-psma-617) and label it with 177lu. the study is open-label and patients will be divided into three groups and monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events to evaluate the safety and therapy response to the 177lu-eb-psma-617.

Eligibility criteria:
inclusion criteria: * progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy. * distant metastases with high psma expression confirmed by 68ga-psma pet/ct within one week before the injection of 177lu-eb-psma-617. exclusion criteria: * a serum creatinine level of more than 150μmol per liter, * a hemoglobin level of less than 10.0 g/dl, * a white-cell count of less than 4.0× 109/l, * a platelet count of less than 100 × 109/l, * a total bilirubin level of more than 3 times the upper limit of the normal range, * a serum albumin level of more than 3.0 g per deciliter, * cardiac insufficiency including carcinoid heart valve disease, * a severe allergy or hypersensitivity to radiographic contrast material, * claustrophobia, and pregnancy or breastfeeding.
tramadol and pain sensitization

Conditions: Pain

Summary: tramadol is a largely used analgesic drug. its role however on sensitization as occurs for example in neuropathic pain is not very well known. this protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.

the study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment

Eligibility criteria:
inclusion criteria: * healthy men * between 18 and 40 years old * written consent given exclusion criteria: * concomitant medication * tramadol hypersensibility * excessive consumption of alcohol, tobacco, coffee, tea or toxicomania

Keywords: pain sensitization analgesia healthy volunteers and pain
the effects of cbt and tdcs on fibromyalgia patients

Conditions: Fibromyalgia; Chronic Pain

Summary: investigators are seeking to determine the effects of cbt, anodal tdcs over left dlpfc, and combined cbt+ tdcs on clinical pain and functioning among a sample of patients with fibromyalgia. this study will be the first randomized, double-blind, controlled study of tdcs technology as an adjunctive pain management strategy for fibromyalgia pain. data from this trial will likely yield information regarding the feasibility and efficacy of tdcs+cbt as a chronic pain-management approach.

patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tdcs during each of the six therapy sessions.

Eligibility criteria:
inclusion criteria: 1. meet the american college of rheumatology criteria for diagnosis of fibromyalgia for at least 1 year. 2. between the ages of 21 and 85 exclusion criteria: 1. other chronic pain conditions 2. on chronic opioid therapy 3. history of seizures 4. are or might be pregnant 5. metal/electronic implants or devices above the waist 6. moderate to severe depression (hdrs \>19) 7. moderate to severe anxiety (bai \>16) 8. latex allergy 9. psychiatric illness other than mild depression or anxiety 10. on medications that lower seizure threshold

Keywords: fibromyalgia pain
the effect of slow stroke back massage on pain and fatigue in women with fibromyalgia

Conditions: Massage Intervention

Summary: fibromyalgia syndrome (fm) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (pins) on physical examination and no specific laboratory findings. t sampling was calculated using power power (g power 3.1.9.4) analysis. the effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by field, et al. (2002). accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% type i error level. the application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas.

he research will be conducted experimentally with the aim of evaluating the effects of slow-stroke back massage in patients followed up in the physical therapy and rehabilitation unit with the diagnosis of fibromyalgia.

Eligibility criteria:
inclusion criteria: * able to communicate verbally, * over 18 years of age, * no vision and hearing loss * who have received medical treatment, * who have never received a slow-stroke back massage before exclusion criteria: * initially volunteered to participate in the study, but did not like the application of slow-stroke back massage * who wants to leave the study for another reason

Keywords: pain fatigue fibromyalgia
optical tissue identification for myocardial architecture

Conditions: Ventricular Septal Defect; Complete Atrioventricular Canal; Tetralogy of Fallot With Pulmonary Stenosis

Summary: the goal of this study is to test the hypothesis that fiberoptic confocal microscopy (fcm) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

this is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (fcm) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. study results will be compared to a cohort of similar surgical patients following standard surgical procedures where fcm was not used. we will analyze pre-and postoperative ecgs to identify conduction abnormalities.

Eligibility criteria:
inclusion criteria: * age 30 days to less than 18 years old * patients with planned surgical repair of: * ventricular septal defect (vsd) * complete atrioventricular canal (cavc) * tetralogy of fallot (tof) with pulmonary stenosis exclusion criteria: * prior history of adverse reaction to fluorescein sodium * prior history of renal failure or abnormal renal function * baseline pr interval \> 220 msec or 98% for age * baseline hr \> 98% for age * underlying genetic syndrome associated with progressive av block or sinus node dysfunction (e.g. holt-oram or nkx2.5) * any surgical repair that requires staging or palliation * pregnant or lactating * exclusions specific to type of surgical repair * apical muscular vsd * tof with pulmonary atresia

Keywords: fiberoptic confocal microscopy cardiac surgery
phase i clinical trial of autologous cd7-car t cell therapy for high-risk acute t-cell leukemia/lymphoma

Conditions: T Cell Lymphoma; T-cell Leukemia

Summary: this is a phase 1 clinical trial of autologous cd7-car t cells in the treatment of high-risk acute t-cell leukemia / lymphoma. twenty subjects will be enrolled. subjects will be pretreated with chemotherapy prior to infusion of car t cells: about 3 days before cells transfusion, the patients who planned to reinfuse car t cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. then this study will be using a 3+3 dose escalation approach from dose 1 (dl-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). below the lowest dose was reinfused at the pi's discretion.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. diagnosed as a high-risk acute t-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen cd7 2. refractory or relapsed t-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks 3. male or female, aged 0-70 years 4. no serious allergic constitution 5. eastern cooperative oncology group (ecog) performance status (oken et al., 1982) score 0 to 2 6. have life expectancy of at least 60 days based on investigator's judgement 7. cd7 positive in bone marrow or peripheral blood or immunohistochemistry 8. candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. and pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (guardian) 9. minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. intracranial hypertension or disorder of consciousness 2. symptomatic heart failure or severe arrhythmia 3. symptoms of severe respiratory failure 4. complicated with other types of malignant tumors 5. diffuse intravascular coagulation 6. serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value 7. suffering from septicemia or other uncontrollable infections 8. patients with uncontrollable diabetes 9. severe mental disorders 10. obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (mri) 11. have received organ transplantation (excluding hematopoietic stem cell transplantation); 12. reproductive-aged female patients with positive blood hcg test 13. screened to be positive of infection of hepatitis (including hepatitis b and c), aids or syphilis
effect of lentils and chickpeas on gut microbiome and metabolic health

Conditions: Dysbiosis

Summary: the primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults. secondary objectives include: * to examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults. * to determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks research interventions: participants will be asked to consume a normal diet supplemented daily with either a) whole-cooked canned lentils, or b) whole-cooked canned chickpeas. the control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.


Eligibility criteria:
inclusion criteria: * between 18 and 30 years old * ability to speak and read in english exclusion criteria: * intake of antibiotics in the last 3 months * intake of pre/pro/postbiotics in the last 3 months * current or past (within the last 6 months) user of tobacco, marijuana, or e-cigarette products * cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction) * gastrointestinal disease (ulcerative colitis, crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, fistulas, suspected or known gastric strictures, gastritis, radiation enteritis, gi bleeding, gastric bezoar, recent gi surgery in the last 3 months, etc..), * neurological disorders (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled or insulin dependent diabetes - a1c \> 9%). * food allergy to study foods (pulses or soy, milk, peanuts, tree nuts) * regular consumption of pulses (\>1 cup/wk for males; \>0.5 cup/wk for females) * current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women) * class 3 obesity (bmi \> 40 kg/m2) * known to be currently pregnant (self-disclosed).

Keywords: fiber gut microbiome pulses chickpea lentil young adults transit time prebiotic metagenomic metabolic health
postconditioning in st-elevation myocardial infarction

Conditions: Myocardial Infarction

Summary: study objectives: to assess the effects of postconditioning on infarct size in patients with st-elevation infarction referred to pci. study design: prospective, randomized, open-label study with blinded endpoint evaluation. included patients will be randomly allocated to postconditioning or control. patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ecg criteria for primary pci are eligible. pci follow established routines. in postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. after this intervention, pci proceeds routinely with stent implantation. in the control group, stent implantation after initial opening proceeds as usual. primary endpoint is final infarct size, determined by mri after 4 months. 260 patients will be included. follow-up is 1 year. inclusion period: 18 - 24 months. clinical implications: reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute st-elevation myocardial infarction. still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. in pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. however, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.


Eligibility criteria:
inclusion criteria: * acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration * an occluded infarct related artery must be demonstrated (timi-flow 0-1) exclusion criteria: * prior myocardial infarction * demonstration of collaterals to the infarcted area * timi-flow \>1 before intervention or timi-flow \<2 after initial balloon inflation * demonstration of a distal occlusion * patients given thrombolytic treatment * patients in cardiogenic shock * any contraindication to mri (magnetic resonance imaging) * unwillingness to participate

Keywords: st-elevation myocardial infarction
comparative study of olive oil with piroxicam gel in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.

application of herbal product has old history in therapy of human diseases. olive oil is one of the important diet in iran which its efficacy in reducing of rheumatic pains was pointed out by avicenna in 10th century. nevertheless, its efficacy is not confirmed by scientific study. in this double blinded study, 200 patients with diagnosed osteoarthritis of knee will be recruited that will randomly be assigned in piroxicam or olive oil group. the piroxicam gel or olive oil will be repackaged in anonymous tubes, which only recognizable via codes. the patients or visiting clinicians will be unaware of content of tubes. the final assessor will be blind to groups and interventions. the efficacy of therapies will be evaluated by means of womac and pgs standard questionnaires.

Eligibility criteria:
inclusion criteria: * men and non-pregnant women, age 40-85 years with primary oa of at least one knee, and a flare of pain after withdrawal of prior therapy with either an oral nsaid or acetaminophen (used at least 3 days per week during the previous month). exclusion criteria: * secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement); corticosteroid use: * oral corticosteroid within the previous 14 days, or * intramuscular corticosteroid within 30 days, or * intraarticular corticosteroid into the study knee within 90 days, * intra-articular corticosteroid into any other joint within 30 days, or * topical corticosteroid at the site of application within 14 days; * ongoing use of prohibited medication including nsaid, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management; - ongoing use of glucosamine or chondroitin (unless used continuously for 90 days prior to study entry); * sensitivity to diclofenac, acetylsalicylic acid (asa) or any other nsaid, acetaminophen, dimethyl sulphoxide, propylene glycol, glycerine or ethanol; clinically-active renal, hepatic or peptic ulcer disease; * history of alcohol or drug abuse; * lactation; * concomitant skin disease at the application site; * current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee;

Keywords: osteoarthritis knee virgin olive oil piroxicam topical
safety and efficacy of ocl 503 in prostate artery embolization

Conditions: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Summary: this is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of ocl 503 in men with bph.

prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, ipss, uroflowmetry, iief, and mri pelvic imaging. following conventional catheter angiography with cone-beam ct to confirm catheter placement and prostatic vasculature, each patient will undergo transarterial embolization with ocl 503. ocl 503 will be administered intra-arterially via microcatheter until there is stasis of blood flow. patient assessments include blood work, ipss, uroflowmetry, iief, mri and patient interviews conducted at 3 months, 6 months, and 12 months post embolization.

Eligibility criteria:
inclusion criteria: * patient has received a diagnosis of bph with moderate to severe luts, as determined by ipss * patient is greater than 50 years of age * patient has had a pelvic examination within the past 6 months * patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy * patient has a qmax below 15 ml/s or acute urinary retention * prostate is larger than 40 cubic centimetres * patient is willing and able to provide written, informed consent exclusion criteria: * known malignancy * serum psa \> 10 ng/ml at screening * advanced atherosclerosis and tortuosity of the iliac arteries * prior transurethral resection of the prostate (turp) * post void retention (pvr) \> 250 ml * chronic use of metronidizole * phytotherapy for bph within last two weeks of screening visit * secondary renal insufficiency due to prostatic obstruction * chronic renal failure (gsr \< 60) * large bladder diverticula or bladder stones * claustrophobia or other contraindications related to performing mri * compromised hematopoietic function * anaphylactic reaction to drug or anesthetic, allergic reaction to iodine or contrast media * investigational drug or experimental therapy in the past 4 weeks * abnormal coagulation profile * allergy to bovine collagen

Keywords: embolization prostate
values-affirmation + education intervention targeting medication adherence in older adults with heart failure

Conditions: Heart Failure

Summary: the goals of this study are to determine the (1) feasibility and (2) acceptability of the study procedures through a pilot randomized controlled trial of a values affirmation intervention targeting medication adherence in adults with heart failure enrolled in cardiac rehabilitation relative to usual care.

heart failure (hf) represents a significant public health concern. medication non-adherence is a modifiable contributor to costly hospital readmissions in older adults with hf. educational interventions improve, but do not eliminate, non-adherence. values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. this study tests a values-affirmation intervention targeting medication adherence in older adults with hf enrolled in cardiac rehabilitation. the objective of this study is to examine the feasibility and acceptability of study procedures and the values-affirmation intervention in a pilot randomized controlled trial. participants will complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices. after the baseline medication monitoring period, participants will be randomly assigned to either the intervention or control condition. intervention participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills in additional to their usual cardiac rehabilitation care. control participants will continue with their usual care. participants will be asked to continue using the medication monitoring devices and to complete a final assessment 30 days later.

Eligibility criteria:
inclusion criteria: * heart failure * enrolled in cardiac rehabilitation * read and understand english exclusion criteria: * current participation in another medication-monitoring clinical or research protocol * new york heart association class iv heart failure * diagnosis of alzheimer's, dementia, or severe cognitive impairment indicated on screening * current suicidality or psychosis